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UltraPrint-Dental Temp C&B UV is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is not more than 28 days in oral environment.

The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary dental restorations. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary dental restorations. Restorations fabricated using the Subject device are one-time use, temporary, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware 3D printers and their nesting software, and post-curing devices.

The provided text is a 510(k) summary for the UltraPrint-Dental Temp C&B UV device and does not describe AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (FREEPRINT temp) through non-clinical performance testing against established standards for dental materials. Therefore, much of the requested information regarding AI/ML models, such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this document.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them, as much as possible for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported device performance in the way one would for an AI/ML diagnostic device with metrics like sensitivity, specificity, or AUC. Instead, it refers to compliance with ISO standards for material properties and biocompatibility as its "acceptance criteria," and the "reported performance" is that the device meets these requirements.

Study Proving Acceptance Criteria Met:

The study proving the device meets these acceptance criteria is described as Non-Clinical Performance Testing.

2. Sample size used for the test set and the data provenance

For material property and biocompatibility testing, "test set" and "data provenance" don't apply in the same way they would for an AI/ML model. The "samples" would be physical specimens of the UltraPrint-Dental Temp C&B UV resin, prepared and cured according to the manufacturing workflow, and subjected to various laboratory tests as prescribed by the ISO standards. The specific number of physical samples used for each test (e.g., how many specimens for flexural strength, how many cell cultures for cytotoxicity) is not detailed in this document. The provenance is implicitly the manufacturer's testing facilities (Guangzhou Heygears Imc. Inc, China) or contracted labs, as these are non-clinical studies. These are prospective tests conducted on manufactured samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable here. "Ground truth" in the context of this device refers to objective measurements against established ISO standards rather than expert interpretation of data. The "experts" involved would be technicians and scientists conducting the laboratory tests and interpreting the results against the numerical criteria defined in the ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable as there is no "adjudication" of expert opinions for ground truth establishment. The results are objective measurements from laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This document is for a dental resin, not an AI-powered diagnostic tool. Clinical data was specifically stated as not included in the submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is compliance with established international standards (ISO standards) for physical material properties and biocompatibility. This involves objective measurements obtained in laboratory settings.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI/ML model.

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